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Second-Line Paclitaxel and Carboplatin Show Promising Results in Advanced Gastric Cancer: Presented at ICACT

By Chris Berrie

PARIS, FRANCE -- February 2, 2005 -- Second-/third-line chemotherapy that combines paclitaxel and carboplatin appears to be well tolerated, with promising response rates and rates of disease stabilisation in patients with advanced gastric cancer.

Final results from a phase 2 trial were presented here on February 2^nd at the 16^th International Conference on Anti-Cancer Treatment.

There are as yet no second/third-line chemotherapy treatments that have shown better than 25% to 35% response rates in gastric cancer; in particular, with respect to any specific gains in duration of response and survival benefit to the patient, stated George Samelis, MD, PhD, Deputy Head, Oncology Department, Hippokration General Hospital of Athens, Athens, Greece.

"Advanced gastric cancer is a lethal disease and we do not have any real chemotherapy combinations that are able to improve the survival and quality of life of these patients," he said.

Following up on a small series of phase 2 trials over the past 10 years or so, the potential of paclitaxel for gastric cancer has emerged, and therefore this study was designed to investigate its possibility as a 2nd/3rd-line chemotherapy approach when combined with carboplatin.

The 22 patients enrolled (73% male; median age, 64 years; range, 43-79 years) had histologically confirmed gastric adenocarcinoma with a performance status of 0-1, and had previously had 5-fluorouracil-based chemotherapies. Furthermore, 41% and 9% had undergone previous operations and radiotherapy, respectively, and 50% had been deemed inoperable.

Treatment consisted of 175 mg/m² paclitaxel and carboplatin at an area under the curve of 5 on day 1, with repeat dosing every 3 weeks. With the total number of cycles administered at 103, the median number of cycles each patient received was 6 (range, 2-9).

Complete and partial responses represented 4.5% and 9.0% of patients, respectively, and progressive disease was achieved in 41%. Stable disease, however, was obtained in 45% of patients. These data gave a median time to progression of 6 months (range, 2-29 months) and a median survival of 7.5 months (range, 3-30 months).

Dr. Samelis stressed that this combination of paclitaxel and carboplatin not only gave a reasonable overall response rate of 13.5%, but more importantly, it represents the first example of second-line chemotherapy for advanced gastric cancer that can provide good stability and quality of life.

He concluded that the next stage of research into this regimen will be to compare these very promising results in randomised phase 3 trials with other established second/third-line chemotherapy regimens to establish the real benefits that this paclitaxel and carboplatin combination is offering towards the quality of life and the survival of patients with advanced gastric cancer.


[Study Title: Second-Line Chemotherapy With Paclitaxel and Carboplatin in Advanced Gastric Cancer (Final Results).]

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